Lost in Translation? How One Pharma Giant Averted Regulatory Delay with AI
What the Translation Missed: How AI Caught Risks Before Regulators Did | Case Study
It started with a scramble. A leading pharmaceutical company was preparing to submit consolidated trial findings to regulators across the EU, Japan, and North America. But dozens of final-phase clinical trial reports—written in French, German, and Japanese—landed on their global regulatory team’s desk just weeks before deadline. Human translators flagged a two-month turnaround. The window? Three weeks.
What was at stake: regulatory delay, launch postponement, and reputational damage with investors. The company turned to aiMDC, leveraging its multilingual AI to process and cross-summarize results across all trial documents. In less than 48 hours, aiMDC extracted, translated, and highlighted efficacy and safety outcomes—flagging inconsistencies between versions that human teams hadn’t caught.
Instead of scrambling, the team responded strategically. With fully source-linked summaries and contextual insights, they corrected translation gaps, ensured scientific integrity, and submitted on time—avoiding a projected $11M in market delay losses and a potential trust hit from regulators.
Client
Environment
Objective
Rapidly extract, align, and validate trial outcomes across languages to meet cross-border submission timelines without errors or delays
What was done
aiMDC processed over 2,000 pages of trial documentation in three languages, automatically extracting core efficacy/safety data, surfacing translation inconsistencies, and producing source-linked summaries in English—ready for regulatory handover
Achievement
With aiMDC, the pharma team avoided a critical delay in their global submission schedule. The AI not only saved an estimated $800K in urgent translation costs but prevented a projected $11M market loss tied to delayed launch. More importantly, it helped uphold scientific credibility with regulators, as aiMDC flagged subtle discrepancies between translated reports—issues that would have passed unnoticed until audit. Instead of reacting under pressure, the company acted with precision, speed, and full confidence in their data’s integrity—cementing internal trust in AI-powered document review
What happens next…
Take control of your document challenges today. Connect with our experts, see aiMDC in action, and discover how precision AI can transform your workflow—saving you time, reducing risks, and boosting results. Ready to lead with confidence? Get started with aiMDC
